Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474975
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
Intra-SURGerY High-resolution Specimen PETCT Imager for Margin Assessment in Early-stage Breast Cancer
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
SURGYPET Intra-SURGerY High-resolution Specimen PETCT Imager for Margin Assessment in Early-stage Breast Cancer as Compared to Gross Pathology a Prospective Non-inferiority Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SURGYPET
Brief Summary:
This study is a diagnostic open-label prospective single-arm non-inferiority clinical trial
The primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma IDC patients by high-resolution specimen Positron Emission TomographyComputed Tomography PETCT imaging
The primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma IDC patients by high-resolution specimen Positron Emission TomographyComputed Tomography PETCT imaging
Detailed Description:
The rationale of this study is to examine the non-inferiority of intraoperative high-resolution specimen PETCT imaging in early-stage breast cancer for the identification of all positive margins of the invasive component during Breast Cancer Surgery BCS as compared to standard-of-care gross pathology evaluation
The PETCT specimen imager is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard
The PETCT specimen imager is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None